Rotavirus Vaccine for Healthy Adults

Overseen by Christina Rostad, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Centers for Disease Control and Prevention

Must not be taking: Corticosteroids, Immunomodulators, Cytotoxic drugs, others

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a study of CDC-9 inactivated rotavirus vaccine (IRV) for intramuscular administration (IM) in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient's immune system responds to the vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, if you are on medications that affect the immune system, you may need to stop them, as chronic use of such medications is an exclusion criterion.

Is the CDC-9 Inactivated Rotavirus Vaccine safe for humans?

The CDC-9 Inactivated Rotavirus Vaccine (IRV) has been developed to improve safety compared to live oral rotavirus vaccines, which have a rare risk of causing intussusception (a serious bowel blockage). While specific safety data for adults is not provided, the vaccine is designed to be a safer alternative for global immunization. ^{1 2 3 4 5}

How does the CDC-9 Inactivated Rotavirus Vaccine differ from other rotavirus treatments?

The CDC-9 Inactivated Rotavirus Vaccine is unique because it is an inactivated vaccine, unlike the commonly used live oral rotavirus vaccines. It is designed to be effective in low-income countries where live vaccines have lower efficacy, and it avoids the rare but severe side effect of intussusception associated with live vaccines. ^{3 4 6 7 8}

Research Team

Christina Rostad, MD

Principal Investigator

Emory Children's Center - Vaccine Research Clinic (ECC-VRC)

Lauren Nolan, PA-C

Principal Investigator

Emory Children's Center - Vaccine Research Clinic (ECC-VRC)

Eligibility Criteria

Healthy adults aged 18 to 45 can participate in this trial. They will be testing a new vaccine for rotavirus. To join, participants must not have any health conditions that could affect the study or their safety.

Inclusion Criteria

I am a man who can father a child and will use condoms.

I am in good health based on my recent medical check-up.

Provides written informed consent prior to any study procedures being performed

Exclusion Criteria

Breastfeeding or plans to breastfeed during the study period

Acute illness within 72 hours prior to enrollment

Positive pregnancy test at screening or prior to each vaccine administration

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three doses of the inactivated rotavirus vaccine (IRV) or placebo administered intramuscularly at Days 1, 29, and 57

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety, reactogenicity, and immunogenicity, including solicited and unsolicited adverse events, and immunogenicity labs

6 months

Multiple visits (in-person and virtual) up to Day 237

Treatment Details

Interventions

• CDC-9 Inactivated Rotavirus Vaccine (IRV) (Virus Therapy)

Trial Overview The trial is studying an inactivated rotavirus vaccine given by muscle injection at two different dose levels (7.5 µg and 3.75 µg) compared with a placebo, administered in three doses over time.

Participant Groups

Group I: 7.5 µg CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Experimental Treatment 2 Interventions

20 healthy adults will be administered via IM injection a single dose of IRV at days 1, 29 and 57

Group II: 3.75 µg CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Experimental Treatment 2 Interventions

20 healthy adults will be administered via IM injection a single dose of IRV at days 1, 29 and 57

Who Is Running the Clinical Trial?

Centers for Disease Control and Prevention

Lead Sponsor

Trials

902

Recruited

25,020,000+

Dr. Debra Houry

Centers for Disease Control and Prevention

Chief Medical Officer

MD, MPH

Dr. Susan Monarez

Centers for Disease Control and Prevention

Chief Executive Officer

PhD

Emory-Children's Center

Collaborator

Trials

5

Recruited

5,001,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Steve Davis

Children's Hospital Medical Center, Cincinnati

Chief Executive Officer since 2021

MD

Daniel Ostlie

Children's Hospital Medical Center, Cincinnati

Chief Medical Officer

MD from University of North Dakota

Bill and Melinda Gates Foundation

Collaborator

Trials

428

Recruited

23,060,000+

Mark Suzman

Bill and Melinda Gates Foundation

Chief Executive Officer since 2020

Bachelor's degree (Hons) from Harvard University, Doctorate in International Relations from Oxford University

Dr. Trevor Mundel

Bill and Melinda Gates Foundation

Chief Medical Officer since 2011

MD from a recognized institution

Findings from Research

A review of 3175 reports from the Vaccine Adverse Event Reporting System (VAERS) found that the MMR vaccine in adults had a low incidence of serious adverse events (5%), with no new safety concerns identified during the study period from 2003 to 2013.

Among reports of pregnant women receiving the MMR vaccine, the majority did not experience adverse events, highlighting the need for better education on vaccine recommendations, as MMR is contraindicated during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Following Measles, Mumps, and Rubella Vaccine in Adults Reported to the Vaccine Adverse Event Reporting System (VAERS), 2003-2013. Sukumaran, L., McNeil, MM., Moro, PL., et al.[2019]

The introduction of rotavirus vaccines, Rotarix and RotaTeq, has been shown to be safe and effective in large clinical trials with over 60,000 infants, significantly reducing the disease burden of rotavirus infection.

Despite their safety, there is a very rare risk of intussusception, which necessitates ongoing postmarketing surveillance to monitor for any unexpected adverse events as the vaccines are administered to a larger population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of postlicensure safety of rotavirus vaccines, with emphasis on intussusception. Bines, JE., Patel, M., Parashar, U.[2009]

A total of 98 confirmed cases of intussusception were reported among infants vaccinated with the rotavirus vaccine, with 60 cases occurring within one week of vaccination, indicating a potential safety concern.

The incidence of intussusception was found to be at least four times higher than expected based on statistical estimates, leading to the voluntary withdrawal of the rotavirus vaccine from the market and the cessation of its routine use in US infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intussusception among recipients of rotavirus vaccine: reports to the vaccine adverse event reporting system. Zanardi, LR., Haber, P., Mootrey, GT., et al.[2019]

The CDC-9 strain inactivated rotavirus vaccine (IRV) has been developed to improve efficacy in infants from low-income countries and enhance safety compared to live oral rotavirus vaccines, which can cause severe side effects like intussusception.

In studies with guinea pigs, the IRV demonstrated strong immune responses, including high levels of IgG and neutralizing activity against various rotavirus strains, indicating its potential as an effective alternative for global immunization efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inactivated human rotavirus vaccine induces heterotypic antibody response: correction and development of IgG avidity assay. Velasquez, DE., Wang, Y., Jiang, B.[2018]

A review of 41,792 adverse event reports related to inactivated poliovirus vaccine (IPV) from 2000 to 2012 found that 95% of reports were for children under 7 years, with the majority being non-serious events, indicating a favorable safety profile for IPV.

The analysis showed no new or unexpected safety issues associated with IPV, and reports of sudden infant death syndrome were consistent with patterns seen in other vaccines, suggesting that IPV does not pose additional risks compared to other immunizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation for global introduction of inactivated poliovirus vaccine: safety evidence from the US Vaccine Adverse Event Reporting System, 2000-12. Iqbal, S., Shi, J., Seib, K., et al.[2017]

The candidate inactivated rotavirus vaccine (IRV) demonstrated strong immunogenicity in gnotobiotic piglets, inducing high levels of rotavirus-specific IgG and neutralizing antibodies after three doses.

The IRV provided effective protection against rotavirus infection, as evidenced by reduced shedding of the virus after an oral challenge, supporting its potential as a viable alternative vaccine for infants in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inactivated rotavirus vaccine induces protective immunity in gnotobiotic piglets. Wang, Y., Azevedo, M., Saif, LJ., et al.[2010]

The oral, live rotavirus vaccine (RRV-TV) is safe and effective for infants, significantly reducing the incidence of severe gastroenteritis caused by rotavirus, which is a leading cause of hospitalizations and healthcare costs in children.

The recommended vaccination schedule includes three doses administered at 2, 4, and 6 months of age, which is expected to prevent most physician visits and at least two-thirds of hospitalizations and deaths related to rotavirus in the United States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rotavirus vaccine for the prevention of rotavirus gastroenteritis among children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). [2017]

Inactivated influenza vaccines (IIVs) are generally safe and well tolerated in pregnant women and children under 5 years old, with low rates of adverse events, although ongoing safety monitoring is essential.

IIVs elicit strong antibody responses, with efficacy rates ranging from 50%-70% in pregnant women and 20%-90% in young children against lab-confirmed influenza, indicating that the benefits of vaccination outweigh potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Immunogenicity, Efficacy and Effectiveness of Inactivated Influenza Vaccines in Healthy Pregnant Women and Children Under 5 Years: An Evidence-Based Clinical Review. Bansal, A., Trieu, MC., Mohn, KGI., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adverse Events Following Measles, Mumps, and Rubella Vaccine in Adults Reported to the Vaccine Adverse Event Reporting System (VAERS), 2003-2013. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Assessment of postlicensure safety of rotavirus vaccines, with emphasis on intussusception. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Intussusception among recipients of rotavirus vaccine: reports to the vaccine adverse event reporting system. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Inactivated human rotavirus vaccine induces heterotypic antibody response: correction and development of IgG avidity assay. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Preparation for global introduction of inactivated poliovirus vaccine: safety evidence from the US Vaccine Adverse Event Reporting System, 2000-12. [2017]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Inactivated rotavirus vaccine induces protective immunity in gnotobiotic piglets. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Rotavirus vaccine for the prevention of rotavirus gastroenteritis among children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety, Immunogenicity, Efficacy and Effectiveness of Inactivated Influenza Vaccines in Healthy Pregnant Women and Children Under 5 Years: An Evidence-Based Clinical Review. [2023]